Compositions for conjugated estrogens and associated methods

Details Compositions for conjugated estrogens and associated methods Compositions for conjugated estrogens and associated methods

A - Human Necessities

61

K

A61K 9/36 (2006.01)

Patent

CA 2539872

Oral conjugated estrogen formulations are disclosed and described. In one aspect, the oral formulation may be a tablet having a core and one or more coatings thereon. In addition to conjugated estrogen ingredients, the core may include one or more organic excipients and one or more inorganic excipients. In one aspect, the organic excipients may include less than about 20 % w/w of a cellulose ingredient, and less than about 50 % w/w of a sugar ingredient. In another aspect, the inorganic excipients may include less than about 10 % w/w of a calcium phosphate tribasic ingredient. In yet another aspect, the formulation does not crack when stored at about 40 ~C and about 75 % relative humidity for about 2 months.

L'invention concerne des préparations à base d'oestrogènes conjugués. Dans un aspect de l'invention, la préparation orale peut être un comprimé constitué d'un noyau et d'un ou plusieurs revêtements recouvrant le noyau. En plus des ingrédients à base d'oestrogènes conjugués, le noyau peut comprendre un ou plusieurs excipients organiques et un ou plusieurs excipients inorganiques. Dans un aspect de l'invention, les excipients organiques peuvent comprendre moins de 20 % en poids environ d'un ingrédient à base de cellulose et moins de 50 % en poids environ d'un ingrédient à base de sucre. Dans un autre aspect de l'invention, les excipients inorganiques peuvent comprendre moins de 10 % en poids environ d'un ingrédient à base de phosphate tribasique de calcium. Dans un autre aspect, la préparation ne craque pas lorsqu'elle est conservée à 40 ·C environ et à une humidité relative de 75 % environ pendant 2 mois environ.

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